Professional Information

Telmisartan / Hydrochlorothiazide

Pronouncation: (tell-mih-SAHR-tan/high-droe-klor-THIGH-uh-zide)
Class: Antihypertensive combination

Trade Names:
Micardis HCT
- Tablets 40 mg telmisartan and 12.5 mg hydrochlorothiazide
- Tablets 80 mg telmisartan and 12.5 mg hydrochlorothiazide
- Tablets 80 mg telmisartan and 25 mg hydrochlorothiazide

Pharmacology

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Telmisartan

Antagonizes the effect of angiotensin II (vasoconstriction and aldosterone secretion) by blocking the angiotensin II (AT ₁ receptor) in vascular smooth muscle and the adrenal gland, producing decreased BP.

Hydrochlorothiazide

Increases chloride, sodium, and water excretion by interfering with transport of sodium ions across renal tubular epithelium.

Indications and Usage

Treatment of hypertension.

Contraindications

Patients with anuria; hypersensitivity to sulfonamide-derived drugs or any component of this product.

Dosage and Administration

The fixed combination is not indicated for initial therapy. The combination may be substituted for the titrated components.

Adults

PO Telmisartan may be used over a dose range of 20 to 80 mg/day, administered once daily. Hydrochlorothiazide is effective in doses of 12.5ߙto 50 mg once daily. The dose may be titrated up to telmisartan 160 mg plus hydrochlorothiazide 25 mg, if necessary.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F).

Drug Interactions

Telmisartan Digoxin

Peak and trough plasma levels may be elevated by telmisartan.

Hydrochlorothiazide Alcohol, barbiturates, narcotics

Increased risk of orthostatic hypotension.

Antidiabetic agents (oral agents and insulin)

Dosage adjustment of antidiabetic agent may be necessary.

Antihypertensive agent

Additive or potentiation of effects.

Cholestyramine, colestipol resins

Impaired absorption of hydrochlorothiazide.

Corticosteroids, adrenocorticotropic hormone

Increased electrolyte depletion, increasing the risk of hypokalemia.

Lithium

Renal Cl of lithium may be reduced, increasing the risk of lithium toxicity.

Nondepolarizing skeletal muscle relaxants (eg, tubocurarine)

Increased effect of the muscle relaxant.

NSAIDs

The diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing, and thiazide diuretics may be reduced.

Potassium supplements

Salt substitutes containing potassium or potassium supplements should not be used without consulting the prescribing physician.

Pressor amines (eg, norepinephrine)

Decreased responsiveness to the pressor amine.

Laboratory Test Interactions

Hydrochlorothiazide

May decrease serum protein-bound iodine levels without signs of thyroid disturbances. May cause diagnostic interference of serum electrolyte levels, blood and urine glucose levels, serum bilirubin levels, and serum uric acid levels.

Adverse Reactions

Impotence; micturition frequency; cystitis.

Hydrochlorothiazide

Renal failure; renal function impairment; interstitial nephritis.

Hematologic

Hydrochlorothiazide

Agranulocytosis; aplastic anemia; leukopenia; hemolytic anemia; thrombocytopenia.

Hepatic

Hydrochlorothiazide

Jaundice (intrahepatic cholestatic).

Metabolic

Telmisartan

Gout; hypercholesterolemia; diabetes mellitus.

Hydrochlorothiazide

Hyperglycemia; glycosuria; hyperuricemia.

Respiratory

Upper respiratory tract infection; bronchitis.

Telmisartan

Asthma; dyspnea; epistaxis.

Miscellaneous

Flu-like symptoms; back pain.

Telmisartan

Allergy; fever; leg pain and cramps; malaise; chest pain; arthritis; arthralgia; myalgia; infection (including fungal); abscess.

Hydrochlorothiazide

Hypersensitivity (including purpura, photosensitivity, urticaria, necrotizing angiitis [vasculitis, cutaneous vasculitis], fever, respiratory distress [including pneumonitis, pulmonary edema], anaphylactic reactions); muscle spasm.

Precautions

Warnings

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, discontinue therapy as soon as possible.

Pregnancy

Category D (second and third trimester); Category C (first trimester), drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

Lactation

Telmisartan

Undetermined.

Hydrochlorothiazide

Excreted in breast milk.

Children

Safety and efficacy not established.

Hypersensitivity

May occur in patients with or without history of allergy or bronchial asthma; cross-sensitivity with sulfonamides also may occur.

Renal Function

Decreases in renal function may occur in patients whose renal function is dependent on the renin-angiotensin system; patients with renal artery stenosis may experience acute renal failure. Use caution in treating patients whose renal function may depend on the activity of renin-angiotensin-aldosterone system (eg, severe CHF). In addition, hydrochlorothiazide may precipitate azotemia and cumulative effects of the drug may develop in patients with impaired renal function.

Hepatic Function

Use with caution. Minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Diabetics

May require adjustments of insulin or oral hypoglycemic agents. Hyperglycemia may occur with thiazide diuretics.

Hyperuricemia

May occur or frank gout may be precipitated in certain patients receiving thiazide therapy.

Hypotension/Volume-depleted patients

Symptomatic hypotension may occur after initiation of telmisartan therapy in patients who are intravascularly volume depleted (eg, those treated with diuretics). Correct these conditions prior to administration of telmisartan or start treatment under close medical supervision. Lightheadedness can occur, especially during the first days of therapy.

Systemic lupus erythematosus

Exacerbation or activation may occur.

Overdosage

Symptoms

Hypotension, dizziness, tachycardia, bradycardia, electrolyte depletion (eg, hypokalemia, hypochloremia, hyponatremia), dehydration.

Patient Information

Instruct patient not to remove tablet from blister until immediately before taking the dose.
Advise patient to take once daily as prescribed without regard to meals but to take with food if GI upset occurs.
Advise patient to try to take each dose at about the same time each day.
Inform patient that drug controls, but does not cure, hypertension and to continue taking drug as prescribed even when BP is not elevated.
Caution patient not to change the dose or stop taking unless advised by health care provider.
Instruct patient to continue taking other BP medications as prescribed by health care provider.
Instruct patient in BP and pulse measurement skills.
Advise patient to monitor and record BP and pulse at home and to inform health care provider if abnormal measurements are noted. Also advise patient to take record of BP and pulse to each follow-up visit.
Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
Instruct patient to lie or sit down if experiencing dizziness or lightheadedness when standing.
Caution patient that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to excessive fall in BP resulting in lightheadedness or fainting.
Instruct diabetic patient to monitor blood glucose more frequently when drug is started or dose is changed and to inform health care provider of significant changes in readings.
Emphasize to hypertensive patient the importance of other modalities on BP: weight control, regular exercise, smoking cessation, moderate intake of alcohol and salt.
Instruct patient to stop taking drug and immediately report any of the following symptoms to health care provider: fainting, swelling of the face, lips, eyelids, or tongue.
Caution patient not to take any prescription or OTC medications, salt substitutes, or dietary supplements unless advised by health care provider.